IU Healing Abutment

GUDID 08800026102465

WARANTEC.Co.,Ltd

Dental implant system

• Primary Device ID: 08800026102465
• NIH Device Record Key: 448cf0a3-8f43-4508-86e3-bc7e10db7f72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IU Healing Abutment
• Version Model Number: IUHA5040
• Company DUNS: 688857820
• Company Name: WARANTEC.Co.,Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800026102465 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172345

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-20
• Device Publish Date: 2023-04-12

On-Brand Devices [IU Healing Abutment]

• 08800026106036: IUHA6060
• 08800026102533: IUHA6050
• 08800026102526: IUHA6040
• 08800026102519: IUHA6030
• 08800026102502: IUHA6020
• 08800026102496: IUHA6010
• 08800026102489: IUHA5060
• 08800026102472: IUHA5050
• 08800026102465: IUHA5040
• 08800026102458: IUHA5030
• 08800026102441: IUHA5020
• 08800026102434: IUHA5010
• 08800026102427: IUHA4060
• 08800026102410: IUHA4050
• 08800026102403: IUHA4040
• 08800026102397: IUHA4030
• 08800026102380: IUHA4020
• 08800026102373: IUHA4010
• 08800026102366: IUHA5060A
• 08800026102359: IUHA5050A
• 08800026102342: IUHA5040A
• 08800026102335: IUHA5030A
• 08800026102328: IUHA5020A
• 08800026102311: IUHA5010A
• 08800026102304: IUHA4060A
• 08800026102298: IUHA4050A
• 08800026102281: IUHA4040A
• 08800026102274: IUHA4030A
• 08800026102267: IUHA4010A
• 08800026102243: IUHA4020A